MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST; SURGICAL MESH

Catalog Number	5954124
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	08/31/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st (device #1).The patient's attorney did not make any allegations regarding the implanted non-bard/davol device.Should additional information be provided a supplemental emdr will be.
Event or Problem Description
Attorney alleges that on (b)(6) 2010, the patient underwent surgery for implant of an unspecified non-bard/davol dulex mesh.It is alleged that on (b)(6) 2012, the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1).As alleged, the patient had unspecified injuries on (b)(6) 2017.As reported, the patient is only making a claim for an adverse patient outcome against the ventralight st (device #1).As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st (device #1).The patient's attorney did not make any allegations regarding the implanted non-bard/davol device.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event.Based on the additional information provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 3 years 2 months post implant of ventralight st mesh, patient was diagnosed with hernia recurrence, adhesions, scar tissue thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence and adhesion as possible complication(s).Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-oct-2011) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: b3 (date of event) this supplemental emdr represents the ventralight st mesh (device #2).An additional emdr was submitted to represent the dulex mesh (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2010, the patient underwent surgery for implant of an unspecified non-bard/davol dulex mesh.It is alleged that on (b)(6) 2012, the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1).As alleged, the patient had unspecified injuries on (b)(6) 2017.As reported, the patient is only making a claim for an adverse patient outcome against the ventralight st (device #1).As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh (device #1).Per operative notes, ¿in the left lower quadrant, some dense adhesions to the sac were divided.There was an additional superior aspect hernia just to the right of midline was identified, adhesions were divided.A cutaneous bridge which had an old piece of mesh was divided, and a dulex mesh (device #1) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with recurrent right flank hernia thereby underwent open repair with the partial removal of dulex mesh (device #1) and implant of ventralight st mesh (device #2).Per operative notes, ¿after extensive lysis of adhesions, the hernia sac was dissected.The previous mesh (device #1) was resected and removed.A ventralight st mesh (device #2) was placed and sutured.¿ (b)(6) 2015 - patient was diagnosed with multi-recurrent ventral incisional hernia thereby underwent open repair with the explant of dulex mesh (device #1) and implant of synthetic mesh.Per operative notes, ¿the hernia sac was found herniated into the sigmoid colon.The adhesions were lysed, and hernia contents were reduced.The fascia was densely scarred.There was a dulex mesh (device #1) below the previous ventralight st mesh (device #2) was removed.The ventralight st mesh (device #2) slightly divided, split and posterior rectus release was performed.Then, recreated the defect using sutures to secure the mesh back together and a synthetic mesh was secured to ventralight st mesh (device #2) with sutures.¿ attorney alleges that the patient had adhesions to small bowel, pain and hernia recurrence.

• Brand Name: VENTRALIGHT ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 8493019
• Report Number: 1213643-2019-02747
• Device Sequence Number: 16501948
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601(17)131128(10)HUVJ1600
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2013
• Device Catalogue Number: 5954124
• Device Lot Number: HUVJ1600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female